This invention relates primarily to devices for the treatment of lymphedema and the use of various instrumentation that can effectively lessen the painful and deleterious aspects of disease as manifested in the body.
The present invention is a Sequential Lymphedema Pump (SLP). A positive pressure pump for extraction of fluid (lymph) from the extremities which functions on the principle of sequential pumping of discrete individual pressure chambers from the most distal part of the extremity to the most proximal part of it. It is regulated by a computer which monitors the pressure of each chamber and corrects the pressure when it lowers. It also monitors the blood pressure, pulse, temperature and active movements of the treated extremity.
The SLP is designed to prevent elevation of pressure in the chambers above a certain percentage of the diastolic pressure. It also insures that no more lymph is extracted than is allowed by the prescribing physician. When any of these parameters exceed those allowed by the prescribing physician, the device instructs patients to contact the physician. The SLP delivers to the physician the history of events leading to the request for the call and the entire history of the use of the SLP. It is primarily geared to patients with Acute and Chronic Lymphedema but it can be used for any other condition causing swelling of the extremities.
Chronic Lymphedema or Elephantiasis of the extremities is a common medical condition. A significant number of such patients, up to eight million persons, suffer from this condition in the U.S.A. Europe has approximately double the number of patients with this problem. Most often Chronic Lymphedema or Elephantiasis is the result of treatments for a number of neoplastic diseases. The causes range from complications after surgery, post irradiation adverse effects, as well as result from trauma, and even sometimes are the result of a the severe cardiac condition. A number of patients have Idiopathic Chronic Lymphedema due to unknown causes. Chronic Lymphedema is most common in the second part of a patients' life but a number of children have it as well. Some patients with venous stasis exhibits similar problems with swelling of their extremities, mostly the legs. These patients are even more numerous than those with Chronic Lymphedema and are presently treated with elastic stockings. However, some of them require other extensive treatments.
There are three stages of Chronic Lymphedema:
    1. Acute Lymphedema or initial Chronic Lymphedema.    2. Moderate (Intermediate) Lymphedema or Soft Chronic Lymphedema.    3. Severe Progressive Chronic Lymphedema or Lymphedema Tarda.
The condition is debilitating, always getting progressively worse until the late stage is developed. Such patients are always totally disabled for any productive work.
There are several ways these clinical problems are presently managed. A medical approach (diuretics) is not highly recommended and is generally possible only in cases of minor edema. More severe cases are treated with elastic stockings or sleeves, manual Lymphedema drainage, and bandaging. These approaches are not very successful and are marginally effective only for moderately severe cases.
End stage of Chronic Lymphedema always requires intensive treatment using manual massages, bandaging and, finally, use of positive pressure pumps. These pumps are cumbersome and require that patients are homebound and are not able to move around during pumping of their extremities which lasts for several hours a day. In addition to all this, when using the present pumps patients commonly suffer from infections of the skin due to poor trophic and oxygenation of the affected extremities and these pumps are prone to generalized overload of fluids and may cause decompensation of the heart. For these reasons, presently available pumps are not very popular with patients.
Due to the confinement of the patients while they have to “pump” their extremities, and due to fear of complications, patients resort to pump devices mostly in the final stage of the disease. Patients are rarely able to hold employment due to the fact that they are required to spend several hours daily in confinement to reduce the edema and are not able to move around during such procedures. If there were a device available to give them a relief from this condition and they were able to maintain relatively normal life activities, they would use such devices sooner in the development of the disease than this is done now.